A Directional View of Global Health Authority eCTD Adoption Status

Adoption Approximately one-third of global health authorities have implemented eCTD today.

Variation Many others continue to operate through alternative or transitional submission frameworks.

Strategic implication For companies filing globally, this variation shapes submission strategy, planning, and execution.

Selected country

Select a country

Click the map to view details

Status appears here

eCTD 4.0 roadmap

Separate transition layer eCTD 4.0 is not counted as a separate adoption category. It reflects selected authorities with visible transition pathways.

FDAVoluntary use active; mandatory pathway targeted for 2029.

EMA / EU CAPPilot and phased transition toward mandatory use for CAPs.

Health CanadaVoluntary and mandatory milestones identified.

PMDAMandatory eCTD 4.0 transition pathway identified.

ANVISAPlanning and pilot pathway associated with eCTD transition.

SwissmedicPilot and voluntary transition milestones identified.

TGA / AustraliaVoluntary eCTD 4.0 transition monitoring following pilot activity; mandatory timing TBD.